In this section you can find detailed answers to questions that are related to the product and its formulation
The Eugedin Complex innovation and competitive advantage lies in its ingredients synergetic effect in boosting the body’s autophagy process, the process that allows the cells to fight viruses. In vitro trials carried out by the university of Bologna (UniBO), confirmed that the active ingredients activate autophagy in different cell types – including intestinal, dermal, monocytes, human epithelial bronchial, and human endothelial cells. The product formulation combines three main components: wheat germ extract (Triticum aestivum, seeds) naturally enriched in spermidine, Clove Oil (Syzygium aromaticum, dried buds) titrated in Eugenol, and Vitamin D.
Spermidine is a polyamine, an organic compound, that is found in wheat germ, green pepper, cauliflower, broccoli, mushrooms, soy products, corn, whole grains and different varieties of cheese. It is a powerful antioxidant and anti-inflammatory and plays a significant role in the metabolism of cells, stabilises DNA, RNA and protein synthesis and contributes to longevity. The European Food Safety Authority has recognised spermidine as a ‘novel food’.
Eugenol is the main extract derived from clove buds. It has strong antimicrobial, antiviral, anti-pyretic and anti-inflammatory properties. It has been used successfully in vitro as an antiviral agent against the Ebola virus. Eugenol is also one of the molecules that in silico studies has been shown to effectively bind the SARS-COV-2 spike protein.
Vitamin D is innate in the human body and is activated during sunlight exposure. It is also found in a small number of foods such as fatty fish, liver, egg yolks, mushrooms and fortified foods. Among its many roles in the body, vitamin D has been found to reduce inflammation and modulate processes such as cell growth and immune function.
Autophagy (or autophagocytosis; from the Ancient Greek αὐτόφαγος autóphagos, meaning “self-devouring” and κύτος kýtos, meaning “hollow” is the natural, conserved degradation of the cell that removes unnecessary or dysfunctional components through a lysosome-dependent regulated mechanism. What this means is that the cells of the body “cleanse” themselves of any unnecessary or damaged components, to facilitate replenishment through the recycling of nutrients necessary for vital functions, homeostasis, aging and development. This mechanism favors the supplying of energy for the cells as well as promotes the elimination of potentially harmful waste.
Defects in autophagy have been linked to various human diseases, including neurodegeneration and cancer, and interest in modulating autophagy as a potential treatment for these diseases has grown rapidly. It has been demonstrated that the coronavirus family blocks the cell authophagy processes to avoid its degradation (Bello-Perez et al. 2020). In fact, there is a complex and concomitant interaction between coronavirus and autophagia, as these viruses exploit the molecular mechanism of autophagy avoiding its protective apoptotic drift and the formation of innate cellular immune responses. 𝛃– coronaviruses do not use the biosynthetic secretory pathway typically used by viruses to leave infected cells. Instead, these viruses exploit the lysosomal trafficking, inhibit the autophagic mechanism and obtain an unconventional cellular exocytosis (Gosh et al. 2020).
Nο, the product cannot be considered a product against the fight of SARS-CoV-2 infections. Supplements are not considered medicines. Dietary supplements are products intended to supplement the diet and increase well-being. They are not medicines and are not intended to treat, diagnose, mitigate, prevent, or cure diseases. Eugedin Complex is a raw material commercialised to be used alone or in combination in other food supplements.
Eugedin Complex contains clove oil, wheat germ as a source of spermidine and vitamin D. The daily recommended dose of this particular supplement raw material is 2 grams/day, corresponding to 380 micrograms of clove oil (304mg of Eugenol), 48 micrograms of Vitamin D (a daily admitted, dose for food supplements) and 16 micrograms of spermidine.
Clinical trials suggest there are no known side effects from spermidine. The EU COMMISSION IMPLEMENTING REGULATION (EU) 2018/1023 of 23 July 2018 specifies that the maximum spermidine dosage in a food supplement intended for the adult population, excluding pregnant and lactating women is 6mg/day. Therefore, the recommended spermidine dose in the mix (16 micrograms) is much lower to the maximum dosage set by the EC IMPLEMENTING REGULATION 2018/1023.
There is no study demonstrating acute toxic effects of eugenol by occupational exposure. The daily recommended dose of Eugedin Complex as a raw material in a food supplement is 2 grams/day, corresponding to 380 micrograms of clove oil (304 micrograms of Eugenol). Clove Oil is classified as GRAS (Generally Recognised As Safe) by FDA and is commonly used as a flavoring agent. Its main component Eugenol, has a No Observed Adverse Effect (NOAEL) of 300 mg/kg per day, corresponding to 21 grams/day for an individual weighting 70kg.
The use of Eugedin Complex at the recommended dose is therefore considered to be safe.
No, the product is not gluten-free
Yes, the product is GMO-free and in agreement with Regulations EC 1829/2003 and 1830/2003. The product does not contain, does not derive and is not made up of Genetically Modified Organisms.
Nο, the product cannot be considered vegan. Despite the fact that the Vitamin D used in Eugedin Complex is vegan and TGD has obtained the necessary certification on it, the rest of the ingredients have not been certified as vegan.
TGD is currently in the process of compiling the product’s dossier to be submitted for a new registration.
There is a wide European regulatory framework covering the product’s ingredients.
The General Food Law Regulation (Regulation EC 178/2002 of the European Parliament and the Council) established the principle and foresaw the creation of an independent organisation called the European Food Safety Authority (EFSA) with the specific task of giving scientific advice based upon scientific assessment of the beneficial health effects and associated risks related to food intake .
The Eugedin Complex product ingredients, notably spermidine and eugenol, fall under two wide categories of EU law regulating their use and specifications. Spermidine is considered a novel food and is therefore regulated under the Novel Foods set of EU regulations and implementing regulations. Eugenol is considered a food flavouring and is therefore regulated under Regulation no 1334/2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods .
However, concerning spermidine and eugenol in particular, the European Commission has implemented two Regulations:
• Commission Implementing Regulation No 141/2014 of 13 February 2014 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance plant oils/clove oil .
• Commission Implementing Regulation (EU) 2020/443 of 25 March 2020 authorizing the change of the specifications of the novel food spermidine-rich wheat germ extract (Triticum aestivum) under Regulation (EU) 2015/2283 of the European Parliament and the Council and amending Commission Implementing Regulation (EU) 2017/2470 (Fig. 1) .
Also, the World Health Organization (WHO) has declared eugenol as a nonmutant and generally recognised as safe (GRAS) molecule .
Eugedin Complex is going to be sold in the form or either powder or – in the case clients asks for it – in capsules. TGD has moved into encapsulating the mix in order to showcase to the potential customer the possibility of the product being sold in a capsule form too.
In order to be shipped to customers, the Eugedin Complex mix of ingredients will be packaged into plastic bags or metal barrels.
TGD has filed a patent for the synergetic effect between spermidine and eugenol and their induction of autophagy in cells.
The Eugedin Complex production process is a rather simple, linear and ultimately cost-effective production process of five key steps:
- Raw materials are wheat germ (bought from Molino Naldoni) and bud clove essential oil (bought from Xeda)
- The wheat germ is then processed. It is dried, pressed and milled into powder
- Eugenol is added and mixed to the wheat germ powder
- The powder consisting now both of spermidine and eugenol is dried out
- The final powder mix is packaged either into plastic bags or metal barrels and is ready to be sold as a raw material
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